Data / Medical devices / United States / Waypoint Orthopedics
Waypoint Orthopedics: FDA-registered device maker in Malvern, PA, United States, 1 510(k) clearance
Waypoint Orthopedics is registered with the FDA (registration 3027595873) in Malvern, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027595873
- Address
- 7 Great Valley Pkwy Ste 295, Malvern, PA, United States, 19355
- Owner or operator
- Waypoint Orthopedics (10088311)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 27, 2023
- Registered through
- 2026
- Brand names listed
- Guided Pedicle System (GPS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Optical Neurosurgical Nerve Locator | QWP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2023 | K222106 | Waypoint GPS | QWP | Substantially Equivalent | Waypoint Orthopedics, Inc. | accessdata.fda.gov |
Updated May 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.